Apparatus and method for removing a clip

ABSTRACT

An endoscopic apparatus comprises a pair of jaws pivotably connected to each other and movable between an open position and a closed position. The jaws comprise respective opposing gripper portions. Each gripper portion comprises a distal end, a proximal end, and an inside surface extending between the distal and proximal ends. At the closed position, the inside surfaces define a jaw gap therebetween. At least a portion of the jaw gap increases in distance along a direction from the distal end toward the proximal end. An actuating mechanism communicates with the jaws for moving the jaws between the open and closed position. In a surgical procedure in which a clip such as a hemostatic clip has been latched around a blood vessel or other tissue, the apparatus can be used to compress the clip and consequently unlatch the clip, thereby releasing the clip from the vessel. Thereafter, the apparatus can be rotated. After rotation, the apparatus can be used to grasp the clip and subsequently remove the clip from the surgical site.

TECHNICAL FIELD

The present invention generally relates to the design and use of adaptedfor manipulating small objects such as surgical clips. Morespecifically, the present invention relates to surgical endoscopicinstruments that can be actuated to unlatch clips from a surgical sitesuch as a ligature and subsequently extract such clips from the surgicalsite.

BACKGROUND ART

Many surgical procedures require vessels or other tissues of the humanbody to be ligated during the surgical process. For example, manysurgical procedures require cutting blood vessels (e.g., veins orarteries), and these blood vessels may require ligation to reducebleeding. In some instances, a surgeon may wish to ligate the vesseltemporarily to reduce blood flow to the surgical site during thesurgical procedure. In other instances a surgeon may wish to permanentlyligate a vessel. Ligation of vessels or other tissues can be performedby closing the vessel with a ligating clip, or by suturing the vesselwith surgical thread. The use of surgical thread for ligation requirescomplex manipulations of the needle and suture mate rial to form theknots required to secure the vessel. Such complex manipulations aretime-consuming and difficult to perform, particularly in endoscopicsurgical procedures, which are characterized by limited space andvisibility. By contrast, ligating clips are relatively easy and quick toapply. Accordingly, the use of ligating clips in endoscopic as well asopen surgical procedures has grown dramatically.

Various types of hemostatic and aneurysm clips are used in surgery forligating blood vessels or other tissues to stop the flow of blood. Suchclips have also been used for interrupting or occluding ducts andvessels in particular surgeries such as sterilization procedures.Typically, a clip is applied to the vessel or other tissue by using adedicated mechanical instrument commonly referred to as a surgical clipapplier, ligating clip applier, or hemostatic clip applier. In manyprocedures, the clip is left in place permanently after application tothe tissue. In other cases, the clip must be removed because, forexample, only temporary occlusion of a vessel is desired, or the cliphas been mistakenly latched to a structure that is not to be ligated. Inthese latter cases, the clip is removed by using a separate instrumentdedicated for that purpose, i.e., a clip removal instrument.

Ligating clips can be classified according to their geometricconfiguration (e.g., symmetric clips or asymmetric clips), and accordingto the material from which they are manufactured (e.g., metal clips orpolymeric clips). Symmetric clips are generally “U”, “V” or “C” shapedand thus are substantially symmetrical about a central, longitudinalaxis extending between the legs of the clip. Symmetric clips are usuallyconstructed from metals such as stainless steel, titanium, tantalum, oralloys thereof. By means of a dedicated clip applier, the metal clip ispermanently deformed over the vessel. An example of one such clip isdisclosed in U.S. Pat. No. 5,509,920 to Phillips et al. An example of ametallic clip applier is disclosed in U.S. Pat. No. 3,326,216 to Wood,in which a forceps-type applier having conformal jaws is used to gripand maintain alignment of the clip during deformation. Such appliers mayadditionally dispense a plurality of clips for sequential application,as disclosed for example in U.S. Pat. No. 4,509,518 to McGarry et al.

With the advent of high technology diagnostic techniques using computertomography (CATSCAN) and magnetic resonance (MRI), metallic clips havebeen found to interfere with the imaging techniques. To overcome suchinterference limitations, biocompatible polymers have been increasinglyused for surgical clips. Unlike metallic clips, which are usuallysymmetric, polymeric clips are usually asymmetric in design and hencelack an axis of symmetry. Inasmuch as a plastic clip cannot bepermanently deformed for secure closure around a vessel or other tissue,latching mechanisms have been incorporated into the clip design toestablish closure conditions and to secure against re-opening of thevessel. For example, polymeric clips are disclosed in U.S. Pat. No.4,834,096 to Oh et al. and U.S. Pat. No. 5,062,846 to Oh et al., both ofwhich are assigned to the assignee of the present invention. Theseplastic clips generally comprise a pair of curved legs joined at theirproximal ends with an integral hinge or heel. The distal ends of thecurved legs include interlocking latching members. For example, thedistal end of one leg terminates in a lip or hook structure into whichthe distal end of the other leg securely fits to lock the clip in place.The distal ends of the clips taught by Oh et al. also include lateralbosses that are engaged by conformal recesses of the jaws of the clipapplier. A clip applier specifically designed for asymmetric plasticclips is used to close the clip around the tissue to be ligated, and tolatch or lock the clip in the closed condition. In operation, the jawsof this clip applier are actuated into compressing contact with the legsof the clip. This causes the legs to pivot inwardly about the hinge,thereby deflecting the hook of the one leg to allow reception therein ofthe distal end of the other leg. A clip applier designed for use withasymmetric plastic clips in an open (i.e., non-endoscopic) surgicalprocedure is disclosed in U.S. Pat. No. 5,100,416 to Oh et al., assignedto the assignee of the present invention.

In addition to compatibility with sophisticated diagnostic techniques,asymmetric clips have other advantages over symmetric clips. Forexample, because asymmetric clips are formed from polymeric materials,the mouths of asymmetric clips can be opened wider than the mouths ofsymmetric clips. This allows a surgeon to position the clip about thedesired vessel with greater accuracy. In addition, a clip of the typedescribed in above-cited U.S. Pat. Nos. 4,834,096 and 5,062,846 can berepositioned before locking the clip on the vessel or before removingthe clip from the vessel, in a process referred to as “approximating”the clip.

As indicated above, instruments employed to install metal and polymericclips are solely dedicated to the clip applying function, and thuscannot be reversely operated to remove the clip once applied.Accordingly, separate tools have been employed for the sole purpose ofreversely deforming and removing clips. In the past, a satisfactoryinstrument for removing latching polymeric clips had not been available.In past instances where a surgeon desired to remove or relocate theclip, the clip had to be physically severed by appropriate cuttinginstruments, such as scalpels, scissors and the like. Such removaltechniques require substantial time and dexterity to safely remove theclip without adverse consequences to surrounding tissue. Accordingly, aneed arose for developing a surgical instrument for removing plasticlatching clips in a manner that released the clip from a latchedcondition in a single piece without destruction of the clip and damageto surrounding tissue. In the case of open surgery, these problems havebeen addressed by an open, forceps-type clip removal instrumentdisclosed in U.S. Pat. No. 6,391,035 to Appleby et al., assigned to theassignee of the present invention. The need remains, however, for apolymeric clip removing instrument having an improved jaw design toenable better handling of and control over such clips, as well as for aclip removing instrument suitable for use in endoscopic-type surgicalprocedures, particularly an instrument that successfully addresses theproblems attending the use of asymmetric clips.

As a general matter, laparoscopic, endoscopic, and other minimallyinvasive surgical techniques enable surgeons to perform complexprocedures through relatively small entry points, or surgical ports, inthe body. The term “laparoscopic” refers to surgical proceduresperformed on the interior of the abdomen, while the term “endoscopic”refers more generally to procedures performed in any portion of thebody. Endoscopic surgery involves the use of an endoscope, which is aninstrument permitting the visual inspection and magnification of a bodycavity. The endoscope is inserted into a body cavity through a cannulaextending through a hole or port in the soft tissue protecting the bodycavity. The port is typically made with a trocar, which includes acutting instrument slidably and removably disposed within a trocarcannula. After forming the port, the cutting instrument can be withdrawnfrom the trocar cannula. A surgeon can then perform diagnostic and/ortherapeutic procedures at the surgical site with the aid of specializedmedical instruments adapted to fit through the trocar cannula andadditional trocar cannulas providing openings into the desired bodycavity.

Some known advantages of minimally invasive surgical techniques includereduced trauma to the patient, reduced likelihood of infection at thesurgical site, and lower overall medical costs. Accordingly, minimallyinvasive surgical techniques are being applied to an increasingly widerarray of medical procedures.

Surgical clip appliers and removers adapted for endoscopic surgicaltechniques typically include a shaft that is inserted through anendoscopic cannula to access a surgical site in a body cavity and a jawassembly disposed at the distal end of the shaft for manipulating asurgical clip at the surgical site. The basic operations of endoscopicclip appliers and removers are as indicated above. The clip applier isused to position the clip over the desired vessel and its jaws areactuated, typically using an actuating mechanism disposed in the handleof the device, to close the clip about the vessel. In certain cases suchas those previously mentioned, the clip remover can be used to unlatchthe clip.

As endoscopic techniques have been developed, certain inadequacies inthe available surgical equipment have become apparent. For example, thejaws of the removing instrument, which are typically used to disengagethe clip from the vessel, may exert unequal pressure on the clip,resulting in a “scissoring” effect and damage to the vessel. Inaddition, the jaws may impart excessive force on the clip andconsequently crush the clip, thereby creating a risk that pieces of theclip are not removed from the body cavity. In prior art devices, theforce applied to the clip has been difficult to control by the surgeonusing the clip removal instrument. In other instances, the clip may notbe properly oriented when it is placed within the jaws, or may slip outof alignment or even be ejected from the jaws during use of the removalinstrument. This can result in the loss and/or crushing of the clip orpieces thereof, damage to tissue, or otherwise unsuccessful use of theremoval instrument.

Moreover, existing clip removal instruments have been designed primarilyfor manipulating symmetric clips, and therefore are not well suited tosatisfy design issues unique to asymmetric clips. For example, whensymmetric clips are closed on a vessel, the opposing legs of the clipapply substantially even pressure to the opposing sides of the vessel.By contrast, the opposing legs of an asymmetric clip can apply varyingpressure to opposing sides of a vessel when the asymmetric clip isclosed. Thus, ideally a clip removal instrument should be designed toaccount for the asymmetry of the clip, so as to avoid theabove-mentioned unequal pressure on the clip and resulting damage to thevessel. Further, lockable asymmetric clips generally function best whenforce is applied at or near the distal ends of the clip legs. Stillfurther, asymmetric clips usually need to be placed under compression tobe unlatched. Conventional clip removal instruments designed forsymmetric clips may not provide the ability to adequately compress orapproximate a clip.

As an additional problem, while clip removers of the prior art arecapable of unlatching the clip, once the clip has been unlatched, thesame instruments are not additionally capable of actually removing theclip from the surgical site and subsequently extracting the clip fromthe body cavity through the surgical port. An additional clip-graspinginstrument has conventionally been required for this purpose. Ittherefore would be advantageous to provide a clip removal instrumentthat is capable of both unlatching the clip as well as grasping the clipfor extraction from the surgical site.

In view of the foregoing discussion, a need is acknowledged by personsskilled in the art to provide an endoscopic clip removing apparatus thatenables improved control over manipulation of a clip, especially asurgical clip and particularly one of asymmetric design. A further needis acknowledged to provide an endoscopic clip removing apparatus that,in use, prevents the clip from being crushed, especially polymeric clipsthat are more prone to breaking in comparison to metal clips, andprevents damage to tissue. A still further need is acknowledged toprovide an endoscopic clip removing apparatus that is capable of notonly unlatching a clip but also thereafter removing the clip from thesurgical site.

DISCLOSURE OF THE INVENTION

According to one embodiment of the present invention, an endoscopicapparatus for unlatching a clip comprises first and second jawspivotably connected to each other and movable between an open positionand a closed position, and an actuating mechanism communicating with thefirst and second jaws for moving the jaws between the open and closedpositions. The first and second jaws comprise respective opposing firstand second gripper portions. Each gripper portion comprises a distalend, a proximal end, and an inside surface extending between the distaland proximal ends. At the closed position, the inside surfaces define ajaw gap therebetween. At least a portion of the jaw gap increases indistance along a direction from the distal ends towards the proximalends.

According to one aspect of this embodiment, the inside surface of eachgripper portion comprises a first frictional section disposed near thedistal end of the respective gripper portion, a second frictionalsection disposed near the proximal end of the respective gripperportion, and a smooth section between the first and second frictionalsections. Preferably, each frictional section comprises a plurality ofserrations, grooves, teeth, or the like. The smooth sections can beprovided by means of a polishing process.

According to another aspect of this embodiment, an elongate memberinterconnects the jaws and the actuating mechanism and is actuatable bythe actuating mechanism.

According to yet another aspect of this embodiment, a sleeve iscoaxially disposed about the elongate member. Advantageously, the sleeveis connected to the jaws so as to be rotatable along the elongatemember, such that rotation of the sleeve causes rotation of the jaws. Itis also advantageous that the sleeve comprise a fluid outlet disposednear the jaws, a fluid inlet axially spaced from the fluid outlet, andan annular fluid passage defined between the sleeve and the elongatemember that communicates with the fluid inlet and the fluid outlet toprovide a flushing mechanism for the apparatus.

Preferably, the actuating mechanism comprises an actuator pin extendingthrough the first and second jaws. The actuator pin is movable between adistal position that corresponds to the open position of the first andsecond jaws, and a proximal position that corresponds to the closedposition of the first and second jaws.

According to another embodiment of the present invention, an endoscopicapparatus for unlatching a clip comprises a pair of pivotably connectedjaws, an axially movable actuator pin extending through the jaws, and areciprocable rod connected to the actuator pin. The jaws compriserespective opposing distal ends, proximal ends and inside surfaces. Eachinside surface includes a proximal rough section and a smooth sectiondistally adjacent to the proximal rough section. At the closed position,a jaw gap defined between the inside surfaces increases in distance in adirection from the distal ends toward the proximal ends. Axial movementof the actuator pin causes rotational movement of the jaws between theopen and closed positions.

According to any of the above embodiments of the present invention, anadvantage is provided wherein, at the closed position of the jaws, therespective inside surfaces of the jaws do not contact each other.According to this aspect, the jaw gap exists between the jaws even atthe respective distal ends thereof when the jaws are at the closedposition.

The present invention also provides a method for unlatching a clip thatis initially provided in a latched state. Such a clip typicallycomprises first and second legs joined at a hinge region of the clip.The first and second legs have respective distal end members that, inthe latched state, are engaged with each other to define an interlockedclip region. According to the method, first and second jaws areprovided. The jaws are pivotably connected to each other and are movablebetween an open position and a closed position. The first jaw comprisesa first distal jaw end, a first proximal jaw end, and a first insidesurface extending between the first distal jaw end and the firstproximal jaw end. The second jaw comprises a second distal jaw end, asecond proximal jaw end, and a second inside surface extending betweenthe second distal jaw end and the second proximal jaw end. At the closedposition, the inside surfaces define a jaw gap therebetween. At least aportion of the jaw gap increases in distance along a direction from therespective distal jaw ends toward the proximal jaw ends. The clip isengaged with the first and second jaws. The engagement is accomplishedby bringing the first jaw into contact with the first leg of the clipand the second jaw into contact with the interlocked clip region andhinge region, with the hinge region being disposed near the secondproximal jaw end. The clip is compressed by moving the first and secondjaws toward their closed position, whereby the respective distal endmembers of the first and second legs of the clip become separated.

This method is particularly advantageous for manipulating clips of thetype wherein the first and second legs of the clip are arcuate, and aconcave inside surface of the first leg faces a convex inside surface ofthe second leg. The method is also particularly advantageous formanipulating clips that are constructed from a polymeric material. Themethod is further advantageous for manipulating clips of the typewherein the distal end member of the first leg of the clip comprises ahook region, and the distal end member of the second leg is retained bythe hook region to define the interlocked clip region in the latchedstate of the clip. During the clip engaging step, the second jawcontacts the hook region of this clip.

According to another aspect of this method, the step of engaging theclip comprises bringing a frictional section of the second insidesurface of the second jaw into contact with the hinge region to preventthe clip from becoming disengaged from, or misaligned in, the first andsecond jaws during the compressing step.

According to another aspect of this method, the step of engaging theclip comprises bringing a first smooth section of the first insidesurface of the first jaw into contact with the first leg of the clip toprevent the clip from being damaged during the compressing step, wherebythe first leg is slidable along the first smooth section during thecompressing step.

According to still another aspect of this method, the step of engagingthe clip comprises bringing a second smooth section of the second insidesurface of the first jaw into contact with the interlocked clip regionto prevent the clip from being damaged during the compressing step,whereby the interlocked clip region is slidable along the second smoothsection during the compressing step.

According to an additional aspect of this method, the jaws are alsoemployed to remove the clip after the clip has been unlatched. Removalof the clip is accomplished according to the following step. The firstand second jaws are disengaged from the clip. The first and second jawsare rotated. The clip is grasped with the first and second jaws bybringing the first jaw into contact with a first side of the hingeregion of the clip and a second jaw into contact with opposing side ofthe hinge region. The first and second jaws can be rotated by rotatingan elongate member attached to the first and second jaws.

According to an additional aspect of this method, the step of graspingthe clip comprises bringing a first frictional section of the firstinside surface of the first jaw into contact with the first side of thehinge region, and bringing a second frictional section of the secondinside surface of the second jaw into contact with the second opposingside of the hinge region.

According to another aspect of this method, an area at which the clip isinitially disposed is flushed by conveying a fluid through a sleeve thatis attached to the first and second jaws. The fluid is conveyed to anoutlet aperture of the sleeve that is disposed near the first and secondjaws.

In another method of the present invention for unlatching a clip that isinitially provided in a latched state, the clip is of the type thatcomprises first and second arcuate legs joined at a hinge section. Thefirst leg terminates at a hook section and the second leg terminates atan end section retained by the hook section in the latched state. Themethod provides first and second jaws that are pivotably connected toeach other and movable between an open position and a closed position.At the closed position, the first and second jaws define a jaw gaptherebetween. At least a portion of the jaw gap increases in distancealong a direction from a distal end of the jaws toward a proximal end ofthe jaws. The clip is engaged with the first and second jaws. This isaccomplished by bringing the first jaw into contact with the first legof the clip and the second jaw into contact with the hook and hingesections of the clip, with the hinge section contacting a proximalfrictional section of the second jaw. The clip is compressed by movingthe first and second jaws toward their closed position, whereby thefirst leg of the clip begins to straighten and the end section of thesecond leg is released from the hook section of the first leg.

It is therefore an object of the present invention to provide anendoscopic clip removing apparatus that enables improved control overmanipulation of a clip.

It is another object of the present invention to provide an endoscopicclip removing apparatus that is compatible for manipulating surgicalclips, especially those of asymmetric design and which are constructedfrom a polymeric material.

It is yet another object of the present invention to provide anendoscopic clip removing apparatus that prevents the clip from beingcrushed and prevents damage to tissue during operation of the apparatus.

It is still another object of the present invention to provide anendoscopic clip removing apparatus that is capable of both unlatching aclip and thereafter removing the clip from the surgical site.

Some of the objects of the invention having been stated hereinabove, andwhich are achieved in whole or in part by the present invention, otherobjects will become evident as the description proceeds when taken inconnection with the accompanying drawings as best described hereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an endoscopic surgical clip removingapparatus provided in accordance with the present invention;

FIG. 1B is a side elevation view of the clip removing apparatusillustrated in FIG. 1A;

FIG. 2A is a side elevation view of a gripping assembly provided withthe apparatus illustrated in FIG. 1A, wherein the gripping assembly isin an open state;

FIG. 2B is a side elevation view of the gripping assembly illustrated inFIG. 2A, wherein the gripping assembly is in a closed state;

FIG. 3 is a top or bottom plan view of the gripping assembly illustratedin FIGS. 2A and 2B;

FIG. 4 is a perspective view of a jaw member provided with the grippingassembly illustrated in FIGS. 2A and 2B;

FIG. 5 is a perspective exploded view of the clip removing apparatusillustrated in FIGS. 1A and 1B;

FIG. 5A is a detailed perspective exploded view of an actuation assemblyprovided with the clip removing apparatus;

FIG. 6 is a cross-sectional, partially cutaway side elevation view ofthe interfacial region between a shaft assembly and the actuatorassembly of the clip removing apparatus;

FIG. 7 is a side elevation view of one example of a surgical clip thatcan be manipulated by the clip removing apparatus of the presentinvention; and

FIGS. 8A-8E are sequential side elevation views illustrating thegripping assembly of the clip removing apparatus engaging, unlatching,and extracting a surgical clip from a surgical site in accordance with amethod of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In the following description of the present invention, the term “remove”is used to mean the process of unlatching a clip, grasping an unlatchedclip, retrieving or extracting an unlatched clip from a surgical sitesuch as through an endoscopic-type pathway, and/or a combination ofthese procedural steps.

Referring now to FIGS. 1A and 1B, an endoscopic clip removal apparatus,generally designated 10, is illustrated in accordance with theinvention. Generally, apparatus 10 comprises a gripping orclip-engagement assembly, generally designated 20; an elongateendoscopic shaft assembly, generally designated 60; and an actuatorassembly, generally designated 90. Gripping assembly 20 is alternatelymovable between an open state (see FIG. 2A) and a closed state (see FIG.2B), and is adapted for manipulating a surgical clip. An example of asuitable clip is described below and illustrated in FIG. 7. Actuatorassembly 90 enables the manual actuation necessary for opening andclosing gripping assembly 20, and thus is mechanically referenced togripping assembly 20 through shaft assembly 60 as described in moredetail below.

Apparatus 10 is particularly designed for use in endoscopic surgicalprocedures. In general terms, an endoscopic procedure involves firstcreating a surgical port at a designated surgical site, i.e., on apatient's body, to provide access into the body cavity. Thereafter, asurgical instrument (e.g., apparatus 10) selected as appropriate for theprocedure is inserted into the body cavity through the surgical port,manipulated in accordance with the procedure, and then removed from thebody cavity back through the surgical port. Thus, shaft assembly 60 ofapparatus 10 should be long enough to reach the intended location withinthe body cavity, while permitting actuator assembly 90 to be comfortablyhandled by the surgeon from outside of the body cavity. The length ofshaft assembly 60 typically ranges from approximately 30 cm toapproximately 35 cm. In addition, the respective overall outer diametersof gripping assembly 20 (when in the closed state) and shaft assembly 60should be at least slightly less than the inside diameter of thesurgical port. As two examples, 5-mm and 10-mm surgical ports arecommonly created in the course of endoscopic procedures.

Referring now to FIGS. 2A-4, gripping assembly 20 and a portion of shaftassembly 60 are illustrated in more detail. FIG. 2A illustrates grippingassembly 20 in its open state, while FIG. 2B illustrates grippingassembly 20 in its closed state. Referring primarily to FIGS. 2A, 2B and4, gripping assembly 20 comprises a pair of opposing first and secondjaws, generally designated 23A and 23B, respectively. Each jaw 23A and23B respectively comprises a gripping region 25A and 25B and a baseregion 27A and 27B. Each gripping region 25A and 25B respectivelycomprises a distal end region 29A and 29B, a proximal end region 31A and31B, and an inside surface, generally designated 33A and 33B. Eachinside surface 33A and 33B extends from its respective distal end region29A and 29B to proximal end region 31A and 31 B. As best shown in FIG.2B, in which gripping assembly 20 is in its fully closed state, a jawgap g is defined between inside surfaces 33A and 33B along therespective lengths of gripping regions 25A and 25B. Jaw gap g existsbetween respective distal end regions 29A and 29B of gripping regions25A and 25B, even at the fully closed state shown in FIG. 2B. Thus, inthe preferred use of apparatus 10, first and second jaws 23A and 23B ofgripping assembly 20 never close completely and their respective insidesurfaces 33A and 33B never contact each other. This feature preventstissue trauma that might otherwise occur from inadvertent or mistakenactuation of apparatus 10 during use. Moreover, along at least a portionof the length of each inside surface 33A and 33B, each inside surface33A and 33B tapers outwardly in the direction from its respective distalend region 29A and 29B to proximal end region 31A and 31B. Thus, jaw gapg increases along this direction from a minimum distance at or neardistal end regions 29A and 29B to a maximum distance at or near proximalend regions 31A and 31B. From the perspective of FIG. 2B, the profile ofjaw gap g could be characterized as being substantially teardrop-shaped.As one example, the distance of jaw gap g increases from approximately0.020 inches to approximately 0.075 inches in the proximal direction.

In addition, as specifically shown in FIGS. 2A and 4, each insidesurface 33A and 33B respectively comprises a distally located rough orhigh-friction region 35A and 35B, a proximally located rough orhigh-friction region 37A and 37B, and a smooth or low-friction region39A and 39B between distal rough region 35A and 35B and proximal roughregion 37A and 37B. It will be noted that FIG. 4 illustrates thedetailed structure of first jaw 23A only, with the understanding thatsecond jaw 23B is symmetrically structured. Each rough region 35A, 35B,37A and 37B is structured, coated and/or treated in any suitable mannerto create areas of high friction on its respective inside surface 33Aand 33B, but without adversely affecting or reacting with any tissuecoming into contact with first and second jaws 23A and 23B. Preferably,each rough region 35A, 35B, 37A and 37B is defined by grooves, teeth,corrugations, or serrations on its respective inside surface 33A and 33Bas shown in FIGS. 2A and 4. Each smooth region 39A and 39B isstructured, coated and/or treated in any suitable manner to create anarea of low friction on its respective inside surface 33A and 33B, againwithout adversely affecting any tissue coming into contact with firstand second jaws 23A and 23B. Preferably, smooth regions 39A and 39B areprovided by polishing inside surfaces 33A and 33B in accordance with asuitable metal polishing process. These features of first and secondjaws 23A and 23B enhance control over the clip being manipulated byapparatus 10, as described below.

As best shown in FIG. 4, in which the structural details of first jaw23A are shown with the understanding that second jaw 23B is similarlystructured, each respective base section 27A and 27B has a pivotpin-receiving aperture or slot 45, a boss-receiving aperture or slot 43,and an actuator pin-receiving aperture or slot 47. Apertures 43, 45 and47 are formed through base section 27A and 27B generally transversely tothe axis of shaft assembly 60. A boss 49 extends transversely from aninside surface 51 of base section 27A and 27B. In the assembly of firstand second jaws 23A and 23B together such as shown in FIG. 3, boss 49 offirst jaw 23A is inserted into boss-receiving aperture 43 of second jaw23B, and boss 49 of second jaw 23B is inserted into boss-receivingaperture 43 of first jaw 23A. Each boss 49 is rotatably supported in itscorresponding boss-receiving aperture 43 to assist in keeping first jaw23A and second jaw 23B properly aligned during movement.

As shown in FIGS. 3 and 5, shaft assembly 60 preferably comprises acentrally disposed elongate member such as rod 63 and a hollow elongatemember such as a sleeve 65 coaxially disposed around rod 63. Insidesurface 51 (see FIG. 4) of each jaw 23A and 23B has a stepped profile sothat, when first and second jaws 23A and 23B are assembled together, atransverse gap exists into which rod 63 or a distal end piece 63Athereof is inserted as shown in FIG. 3. As also shown in FIG. 3, at thedistal end of shaft assembly 60, sleeve 65 comprises a cut-out sectiondefining two or more sleeve extensions 67A and 67B. In assemblingapparatus 10, first and second jaws 23A and 23B are assembled togetheras described above and then inserted into the distal end of shaftassembly 60. First and second jaws 23A and 23B are inserted to a pointat which pivot pin-receiving apertures 45 (see FIG. 4) are aligned withcorresponding sleeve apertures 69A and 69B formed through sleeveextensions 67A and 67B, respectively. A suitable pivot pin 71 (e.g., arivet) is then inserted through sleeve apertures 69A and 69B and pivotpin-receiving apertures 45 and secured by conventional means. In theassembled form, first jaw 23A and second jaw 23B rotate about pivot pin71 in opposite senses to enable gripping assembly 20 to be actuatedbetween the open state (FIG. 2A) and the closed state (FIG. 2B) in ascissors-like fashion.

As shown in FIGS. 2A, 2B and 3, shaft assembly 60 further comprises anactuator pin 75 transversely disposed through rod 63 near the distal endthereof, and sleeve extensions 67A and 67B comprise sleeve slots 77A and77B, respectively. In assembling apparatus 10, actuator pin 75 isinserted through respective actuator pin-receiving apertures 47 (seeFIG. 4) of first and second jaws 23A and 23B (see FIG. 4) as well asthrough sleeve slots 77A and 77B. The movement of actuator pin 75 withinactuator pin-receiving apertures 47 and sleeve slots 77A and 77B iseffected by actuator assembly 90 through the interconnection of rod 63and actuator assembly 90 (see FIGS. 5 and 6). The configuration ofactuator pin-receiving apertures 47 and sleeve slots 77A and 77B, andtheir positions relative to each other and to actuator pin 75 afterassembly of apparatus 10, enable gripping assembly 20 to move from theopen position shown in FIG. 2A to the closed position shown in FIG. 2Bas a result of the linear actuation of rod 63 by actuator assembly 90.For instance, in the embodiment illustrated in FIG. 4, actuatorpin-receiving aperture 47 is oriented obliquely with respect to thelongitudinal axis along which rod 63 is actuated. In FIG. 2A, theforward or distal position of actuator pin 75 in relation to sleeveslots 77A and 77B is associated with the open state of gripping assembly20. In FIG. 2B, the retracted or proximal position of actuator pin 75 inrelation to sleeve slots 77A and 77B is associated with the closed stateof gripping assembly 20. That is, retraction of rod 63 (see, e.g., FIG.3) in direction indicated by arrow A in FIG. 2B causes actuator pin 75to bear against the obliquely oriented inside surfaces of actuatorpin-receiving apertures 47 (see FIG. 4), thereby causing first jaw 23Aand second jaw 23B to rotate to the closed state as indicated by arrowsB and C, respectively.

Referring now to the exploded views of FIGS. 5 and 5A, the variouscomponents of apparatus 10 according to a preferred embodiment areillustrated prior to the completed assembly of apparatus 10 illustratedin FIGS. 1A and 1B. In this embodiment, actuator assembly 90 is designedfor manual actuation by the surgeon. Actuator assembly 90 comprises atwo-piece handle that includes a first handle portion 93A and a secondhandle portion 93B connected together at respective pivot locations 97Aand 97B with a suitable pin or fastening element 101. A pair of arcuatespring elements 105A and 105B contact each other at their upper endsbetween first and second handle portions 93A and 93B, and are connectedto first and second handle portions 93A and 93B using respectivefastening elements 107A and 107B. As a result, first handle portion 93Ais biased away from second handle portion 93B. Rod 63 of shaft assembly60 is inserted through sleeve 65 to interconnect gripping assembly 20with actuator assembly 90. Preferably, rod 63 mechanically communicateswith first handle portion 93A by providing rod 63 with a ball-shapedproximal end 63B that is inserted into a socket 109 formed in firsthandle portion 93A (see FIG. 6). Socket 109 can be sealed with asuitable plug 111. It can thus be seen that upon squeezing handleportions 93A and 93B toward each other, first handle portion 93Aretracts rod 63 and actuator pin 75 to the position shown in FIG. 2B tomove gripper assembly 20 to its closed state, whereby a clip can begrasped and manipulated as appropriate to the procedure being performed.

Referring to FIGS. 5, 5A and 6, sleeve 65 of shaft assembly 60 isattached to actuator assembly 90 so as to enable sleeve 65 to be rotated360 degrees about the longitudinal axis of shaft assembly 60. Becausesleeve 65 is affixed to gripper assembly 20 as described above withreference to FIGS. 2A, 2B and 3, rotation of sleeve 65 likewise causesrotation of gripper assembly 20. As described below, this rotation canbe accomplished while gripper assembly 20 is within a body cavity at asurgical site, and thus can be useful in performing appropriatemanipulations.

Continuing with FIGS. 5, 5A and 6, to facilitate rotation of sleeve 65,sleeve 65 is preferably attached to a knob 115 or similar componentadapted for manipulation by the user. In the preferred configuration,knob 115 is rotatably attached to a barrel element 117. Barrel element117 is retained within an axial bore 115A of knob 115 by a washer 119and C-clip 121. A number of elongate recesses 117A are formed around thecircumference of barrel element 117. To provide a rotational indexingaction for shaft assembly 60 with respect to actuator assembly 90, eachelongate recess 117A sequentially interacts with a spring-loaded ballbearing assembly transversely disposed in a radial bore 115B of knob115. The spring-loaded ball bearing assembly comprises a ball 123, aspring 125, and a retaining element 127. Ball 123 is biased by spring125 into a selected elongate recess 117A to define a given indexposition. Knob 115 is indexed to the next position (either clockwise ofcounterclockwise) by rotating knob 115 in relation to stationary barrelelement 117, which causes ball 123 to roll over barrel element 117 andinto the next elongate recess 11 7A. Barrel element 117 is inserted intoan axial bore 129 of second handle portion 93B of actuator assembly 90.As shown in FIG. 6, barrel element 117 is fixedly secured within bore129 of second handle portion 93B by inserting a radial element 131having a pointed tip through a radial bore 133 of second handle portion93B until the pointed tip engages a depression 117B in barrel element117. By this configuration, knob 115 and shaft assembly 60 can berotated in an indexing fashion with respect to barrel element 117 andfirst and second handle portions 93A and 93B of actuator assembly 90.

As best shown in the cross-sectional view of FIG. 6, shaft assembly 60is mechanically referenced to actuator assembly 90 by connecting rod 63to first handle portion 93A as described above, and further by insertingsleeve 65 and/or a collar 135 coaxial with sleeve 65 into the distalsection of axial knob bore 115A. Sleeve 65 is secured to collar 135 suchas by press-fitting or welding. An annular spacer or seal member 137 isdisposed at the proximal end of sleeve 65, and is coaxially interposedbetween collar 135 and rod 63. It can be seen that in connecting withfirst handle portion 93A, rod 63 extends through sleeve 65, axial knobbore 115A, barrel element 117, and second handle portion 93B.

It can be further seen in FIG. 6 that, upon assembly of apparatus 10, anannular passage 139 is defined between the inner surface of sleeve 65and the outer surface of rod 63. Annular passage 139 provides a fluidpassage that traverses the length of shaft assembly 60 and terminates atoutlets located at or near the interface between shaft assembly 60 andgripper assembly 20, such as outlets 131A and 131B indicated in FIGS. 2Aand 2B. In the preferred embodiment illustrated in FIGS. 5, 5A and 6,another radially disposed bore 115C formed through knob 115 serves asthe fluid inlet into annular passage 139. A fitting 141 is mated toradial bore 115C and extends through a bore 135A in collar 135 toaccommodate the connection of a suitable fluid supply source, such as asyringe and/or tubing, to annular passage 139 of shaft assembly 60.Fitting 141 can also be employed to retain collar 135 and sleeve 65within axial knob bore 115A. After using apparatus 10, the user canflush apparatus 10 with a suitable flushing fluid such as deionizedwater and clean any gross debris residing on the components of gripperassembly 20. A resilient closure element 145 is connected to fitting 141to close the fluid inlet during non-use of the flushing system.Preferably, closure element 145 comprises a cap 145A and a strap 145B.Strap 145B is annularly attached to fitting 141 to conveniently retainclosure element 145 with apparatus 10 when not in use. To close fitting141, strap 145B is folded over and cap 145A pressed onto fitting 141.

As indicated previously, apparatus 10 is particularly useful forremoving a hemostatic clip that has been previously latched around avessel or other type of tissue to ligate the vessel and thereby stop orreduce the flow of fluid through the vessel. Referring now to FIG. 7, ahemostatic clip, generally designated 212, is illustrated as one exampleof a clip suitable for manipulation by apparatus 10. Clip 212 can beconstructed from any suitable biocompatible material, such as certainmetals and polymers. In the particular embodiment represented in FIG. 6,clip 212 comprises a one-piece integral polymeric body formed of asuitable strong biocompatible engineering plastic of the type commonlyused for surgical implants. Suitable examples include polyethyleneterephthalate (PET), polybutylene terephthalate (PBT) polyoxymethylene,or other thermoplastic materials having similar properties that can beinjection-molded, extruded or otherwise processed into like articles.Similar clips are described in detail in commonly assigned U.S. Pat. No.4,834,096 to Oh et al. and U.S. Pat. No. 5,062,846 to Oh et al., thedisclosures of which are incorporated herein in their entireties.

The body of clip 212 comprises a first or outer leg 222 and a second orinner leg 224 joined at their proximal ends by an integral hinge section226. Outer leg 222 has a concave inner surface 228 transitioning to acurved, C-shaped hook section 230 at its distal end defining a latchingrecess 231. Inner leg 224 has a convex inner surface 232 that iscomplementary to concave inner surface 228 in the closed or latchedposition of clip 212, which is shown in FIG. 8A. Thus, a vessel aroundwhich clip 212 is applied can be completely occluded in use. Inner leg224 has a pointed tip 234 at its distal end. As such, convex innersurface 232 of inner leg 224 and concave inner surface 228 of outer leg222 have substantially matching radii of curvature. Hook section 230 isdistally reversely curved inwardly, and has a transverse beveled surface236. Beveled surface 236 and concave inner surface 228 define recess231, which is adapted for conformally engaging tip 234 in the latchedcondition of clip 212. Adjacent the distal end of the outer leg 222 andimmediately inwardly of hook section 230, a pair of cylindrical bosses240 are formed coaxially on the opposed lateral surfaces of outer leg222. Bosses 240 project outwardly beyond convex outer surface 242 ofouter leg 222. At the distal end of inner leg 224, a pair of cylindricalbosses 244 are formed coaxially on opposed lateral surfaces of inner leg224 at the tip 234, and extend longitudinally forwardly beyond tip 234.

In the use of clip 212, bosses 240 and 244 are engaged by an appropriateclip applicator instrument, such as the type described in theaforementioned U.S. Pat. No. 5,100,416, and are pivoted inwardly therebyabout hinge section 226 to engage tip 234 at the end surface of hooksection 230. Further pivotal movement of the applicator instrumentlongitudinally elongates outer leg 222 and deflects hook section 230,allowing tip 234 to align with recess 231. Upon release of theapplicator instrument, tip 234 snaps into and is conformably seated inrecess 231, at a latched condition shown in FIG. 8A. In the latchedcondition, tip 234 is engaged between concave inner surface 228 andbeveled surface 236, thereby securely clamping a designated vessel orother tissue between concave inner surface 228 and convex inner surface232.

Another example of a particularly suitable clip is the HEM-O-LOK® clipcommercially available from the assignee of the present invention. Theseclips are currently available in sizes designated “M”, “ML”, and “L”.Apparatus 10 of the present invention is capable of handling all threesizes of HEM-O-LOK® clips.

Referring now to FIGS. 8A-8E, an example of the operation of apparatus10 will now be described, in which apparatus 10 is used to unlatch aclip and remove the clip from a surgical site. In describing theoperation of apparatus, clip 212 just described with reference to FIG. 7will be referred to for illustrative purposes. Also for illustrativepurposes, it will be assumed that clip 212 initially resides within abody cavity in its latched condition in ligating relation to a vessel orother tissue, and an appropriate surgical port has been created throughthe patient's body (such as by using a trocar) to provide access to theinternal site of the ligature.

In the operation of apparatus 10, the surgeon or other user squeezesfirst and second handles 93A and 93B (see FIGS. 1A and 1B) to actuategripper assembly 20 of apparatus 10 into its closed state shown in FIG.2B, and then inserts closed gripper assembly 20 through the surgicalport to the surgical site where clip 212 is located in the latchedcondition. Once gripper assembly 20 reaches the surgical site, thesurgeon then releases the applied squeezing force on handle portions 93Aand 93B, allowing spring elements 105A and 105B (see FIGS. 1A and 1B) tobias handle portions 93A and 93B outwardly and gripper assembly 20 toreturn to the open state shown in FIG. 2A. As shown in FIG. 8A, thesurgeon then longitudinally aligns gripper assembly 20 into engagementwith clip 212 such that smooth region 39A of first inside surface 33Acontacts outer convex surface 242 of first leg 222 of clip 212, smoothregion 39B of second inside surface 33B contacts hook section 230, andproximal rough region 37B of second inside surface 33B contacts hingesection 226. Partial actuation of gripper section 20 may be necessary toeffect the contact and alignment with clip 212. The alignment allows thesurgeon to have complete control over clip 212 throughout the remainingsteps of the clip removal procedure. It will be noted that gripperassembly 20 is symmetrically structured, such that the respectivepositions of first and second jaws 23A and 23B in relation to clip 212could be reversed.

With gripping assembly 20 properly aligned in engagement with clip 212,the surgeon then begins to squeeze handle portions 93A and 93B (seeFIGS. 1A and 1B). This causes first and second jaws 23A and 23B to movetoward each other and hence toward the closed state, thereby bearing onfirst and second legs 222 and 224 of clip 212 to compress clip 212. Asgripping assembly 20 compresses clip 212, first leg 222 begins tostraighten or flatten out. While first leg 222 is being straightened,hook section 230 is free to move forwardly toward the distal end ofgripping assembly 20 and pivot outwardly. Smooth surfaces 39A and 39Bfacilitate the straightening of first leg 222 and the concomitantmovement and pivoting of hook section 230, as first leg 222 and hooksection 230 are permitted to slide along smooth surfaces 39A and 39B,respectively. Moreover, smooth surfaces 39A and 39B prevent grippingassembly 20 from crushing or otherwise damaging clip 212. At the sametime, however, proximal rough region 37B of second inside surface 33Bmaintains contact with hinge section 226 of clip 212. The retention ofhinge section 226 on proximal rough region 37B prevents significantmovement of hinge section 226 during compression, thereby defeating thetendency of clip 212 to jump out or otherwise become disengaged fromgripper assembly 20. Other than the restriction on hinge section 226,second leg 224 is unrestrained, and thus first leg 222 could becharacterized as lengthening, straightening, or otherwise moving withrespect to second leg 224 during compression of clip 212.

The compression of clip 212 and concomitant yielding or deformation ofhook section 230 in effect causes tip 234 of second leg 224 to beprogressively withdrawn from recess 231 of hook section 230. As shown inFIG. 8B, tip 234 eventually clears beveled surface 236 and deflects toits unlatched condition under the inherent biasing of the compressedclip configuration. Upon further release, clip 212 begins to assume thefully open, unlatched condition shown in FIG. 8C.

At this point, apparatus 10 can be withdrawn from the surgical site.Conventionally, a separate instrument is utilized to retrieve clip 212and remove it from the surgical site, through the trocar cannula andsurgical port, and out from the patient's body. In accordance with anaspect of the present invention, however, apparatus 10 can alsoadvantageously be used to extract clip 212 from the patient's body,thereby eliminating the need for a separate retrieval instrument. Asshown in FIGS. 8D and 8E, this is preferably accomplished by rotatingsleeve 65 of shaft assembly 60, and consequently gripper assembly 20, 90degrees or thereabouts as indicated by arrow D, so that first and secondjaws 23A and 23B of gripper assembly 20 can be actuated into graspingthe lateral surfaces of clip 212. The respective distal rough regions35A and 35B of first and second inside surfaces 33A and 33B of first andsecond jaws 23A and 23B facilitate the grasping of clip 212 in thismanner, as well as enhance the users control over clip 212 during thesubsequent extraction of clip 212 from the body cavity.

It can therefore be seen from the foregoing description that the presentinvention provides an apparatus and method for removing a clip that hasbeen attached to a vessel or other tissue for ligating purposes. Theapparatus is capable of removing the clip by both unlatching the clip aswell as subsequently grasping the clip in order to remove the clip fromthe surgical site. The apparatus is particularly adapted for endoscopicprocedures. The structure of the apparatus enables improved control overmanipulation of the clip by the user thereof. The apparatus isstructured so as to ensure that the clip does not escape the jaws of theapparatus during compression of the clip, and that the clip does notbecome misaligned or damaged. The apparatus is further structured so asto prevent damage to the vessel or other tissue while the clip is beingmanipulated.

It will be understood that various details of the invention may bechanged without departing from the scope of the invention. Furthermore,the foregoing description is for the purpose of illustration only, andnot for the purpose of limitation—the invention being defined by theclaims.

1. An endoscopic apparatus for unlatching a clip, comprising: (a) firstand second jaws pivotably connected to each other and movable between anopen position and a closed position, the first and second jawscomprising respective opposing first and second gripper portions, eachgripper portion comprising a distal end, a proximal end, and an insidesurface extending between the distal and proximal ends wherein, at theclosed position, the inside surfaces define a jaw gap therebetween, andat least a portion of the jaw gap increases in distance along adirection from the distal ends toward the proximal ends; and (b) anactuating mechanism communicating with the first and second jaws formoving the jaws between the open and closed positions.
 2. The apparatusaccording to claim 1 wherein the inside surface of each gripper portioncomprises a frictional section disposed near the proximal end of therespective gripper portion, and a smooth section distally adjacent tothe frictional section.
 3. The apparatus according to claim 2 whereineach frictional section comprises a plurality of serrations.
 4. Theapparatus according to claim 2 wherein each smooth section is polished.5. The apparatus according to claim 1 wherein, at the closed position ofthe first and second jaws, the respective inside surfaces of gripperportions do not contact each other.
 6. The apparatus according to claim1 wherein the inside surface of each gripper portion comprises a firstfrictional section disposed near the distal end of the respectivegripper portion, a second frictional section disposed near the proximalend of the respective gripper portion, and a smooth section between thefirst and second frictional sections.
 7. The apparatus according toclaim 1 wherein the distance of the jaw gap increases from approximately0.020 to approximately 0.075 inches.
 8. The apparatus according to claim1 comprising an elongate member interconnecting the jaws and theactuating mechanism and actuatable by the actuating mechanism.
 9. Theapparatus according to claim 8 comprising a sleeve coaxially disposedabout the elongate member.
 10. The apparatus according to claim 9wherein the sleeve is connected to the jaws and is rotatable about theelongate member, and wherein rotation of the sleeve causes rotation ofthe jaws.
 11. The apparatus according to claim 9 wherein the sleevecomprises a fluid outlet disposed near the jaws, a fluid inlet axiallyspaced from the fluid outlet, and an annular fluid passage definedbetween the sleeve and the elongate member and communicating with thefluid inlet and the fluid outlet.
 12. The apparatus according to claim11 comprising a knob attached to the sleeve and rotatable therewith, theknob defining the fluid inlet.
 13. The apparatus according to claim 1wherein the actuating mechanism comprises an actuator pin extendingthrough the first and second jaws, the actuator pin movable between adistal position corresponding to the open position of the first andsecond jaws and a proximal position corresponding to the closed positionof the first and second jaws.
 14. The apparatus according to claim 13wherein each jaw comprises a base portion adjacent to its respectivegripper portion, each base portion comprises a slot, and the pinactuator extends through each slot.
 15. An endoscopic apparatus forunlatching a clip, comprising: (a) a pair of pivotably connected jawsmovable between an open position and a closed position and comprisingrespective opposing distal ends, proximal ends and inside surfaces, eachinside surface including a proximal rough section and a smooth sectiondistally adjacent to the proximal rough section, wherein, at the closedposition, a jaw gap defined between the inside surfaces increases indistance in a direction from the distal ends toward the proximal ends;(b) an axially movable actuator pin extending through the jaws, whereinaxial movement of the actuator pin causes rotational movement of thejaws between the open and closed positions; and (c) a recriprocable rodconnected to the actuator pin.
 16. The apparatus according to claim 15wherein, at the closed position, the jaw gap exists between therespective distal ends of the jaws.
 17. The apparatus according to claim16 wherein, at the closed position, the jaw gap between the respectivedistal ends of the jaws is between approximately 0.020 and approximately0.075 inches in distance.
 18. The apparatus according to claim 15wherein each proximal rough section comprises a plurality of serrations.19. The apparatus according to claim 15 wherein each smooth section ispolished.
 20. The apparatus according to claim 15 wherein each insidesurface includes a distal rough section, and each corresponding smoothsection is disposed between the corresponding distal rough section andproximal rough section.
 21. The apparatus according to claim 15comprising a rotatable sleeve generally coaxially disposed about the rodand coupled to the jaws, wherein rotation of the sleeve causes rotationof the jaws about an axis generally collinear with the rod. 22.(canceled)
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